Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001510437
Ethics application status
Not required
Date submitted
21/10/2016
Date registered
1/11/2016
Date last updated
1/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Real-life effectiveness of an online asthma education, monitoring, assessment and management tool - Giving Asthma Support to Patients (GASP)
Scientific title
Real-life effectiveness of an online asthma education, monitoring, assessment and management tool - Giving Asthma Support to Patients (GASP)
Secondary ID [1] 290369 0
Nil known
Universal Trial Number (UTN)
U1111-1188-9372
Trial acronym
GASP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 300667 0
Condition category
Condition code
Respiratory 300517 300517 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
8
Target follow-up type
Years
Description of intervention(s) / exposure
This is a retropsective cohort study looking at GASP data collected during routine/standard care of patients with asthma from November 2008 till June 2016. All data are stored at Comprehensive Health Ltd (Waitemata Dirtrict Health Board) in a confidential secured database and only anonymised patient data are used for analysis.

The online GASP tool is used as part of the standard asthma assessment in priomary care. It includes standard asthma assessment questions and provides an online patient record. GASP aids the nurse/doctor in their assessment by providing prompts during the assessment process, aids with diagnosis and recommends treatment (medication) options including allergy avoidance. This assessment tool is used everytime the patient visits the practice with the patient consenting to the use of their data for unannoynomised data analysis at a future date. The GASP tool records all patients demographics, medical history, symptoms, lung function results, medication use, smoking hisytory, adherance and inhaler technique.
Intervention code [1] 296188 0
Not applicable
Comparator / control treatment
A retrospective cohort study was undertaken to evaluate the effectiveness of GASP. Data for patients aged 5-64 years in primary care (Waitemata district of Auckland) with uncontrolled asthma who had completed a minimum of two GASP assessments between 1 November 2008 and 16 June 2016 was extracted from a secure self-populating database. Outcome measures were compared between each patient’s visits 1 (November 2008) and 2 (June 2016) assessments. All patients first assessments was done in the month of November 2015 and their last/final assessment was completed in the month of June 2016.
Control group
Historical

Outcomes
Primary outcome [1] 299941 0
Asthma exacerbation assessed from medical records/history file.
Timepoint [1] 299941 0
First assessment (aka Visit 1) was conducted in the month of November 2008 for all patients and the final visit/assessment (aka Visit 2) was conducted in the month of June 2016 for all patients.
Primary outcome [2] 299942 0
Hospital admissions assessed from medical records/history file.
Timepoint [2] 299942 0
First assessment (aka Visit 1) was conducted in the month of November 2008 for all patients and the final visit/assessment (aka Visit 2) was conduicted in the month of June 2016 for all patients.
Secondary outcome [1] 328592 0
Courses of oral corticosteroids assessed from medical records/history file.
Timepoint [1] 328592 0
First assessment (aka Visit 1) was conducted in the month of November 2008 for all patients and the final visit/assessment (aka Visit 2) was conduicted in the month of June 2016 for all patients.
Secondary outcome [2] 328593 0
Requirement for releiver asthma medication assessed from medical records/history file.
Timepoint [2] 328593 0
First assessment (aka Visit 1) was conducted in the month of November 2008 for all patients and the final visit/assessment (aka Visit 2) was conduicted in the month of June 2016 for all patients.
Secondary outcome [3] 328594 0
Smoking history assessed from medical records/history file.
Timepoint [3] 328594 0
First assessment (aka Visit 1) was conducted in the month of November 2008 for all patients and the final visit/assessment (aka Visit 2) was conduicted in the month of June 2016 for all patients.
Secondary outcome [4] 328595 0
Symptoms scores (night and day) assessed from medical records/history file.
Timepoint [4] 328595 0
First assessment (aka Visit 1) was conducted in the month of November 2008 for all patients and the final visit/assessment (aka Visit 2) was conduicted in the month of June 2016 for all patients.
Secondary outcome [5] 328596 0
Activity limitations assessed from medical records/history file.
Timepoint [5] 328596 0
First assessment (aka Visit 1) was conducted in the month of November 2008 for all patients and the final visit/assessment (aka Visit 2) was conduicted in the month of June 2016 for all patients.
Secondary outcome [6] 328597 0
Inhaler technique assessed from medical records/history file.
Timepoint [6] 328597 0
First assessment (aka Visit 1) was conducted in the month of November 2008 for all patients and the final visit/assessment (aka Visit 2) was conduicted in the month of June 2016 for all patients.

Eligibility
Key inclusion criteria
Patients diagnosed with asthma between the ages of 5 -64yrs
Minimum age
5 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with COPD or other lung diseases.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Data will be compared between all patients visit 1 November 2008, (pre GASP intervention) and visit 2 (June 2016, post GASP intervention) over the 8 yr period using IBM SPSS Statistics (Version 20.0.1). Ethical approval is not required as this is an analysis of anonymised records from a self-populating secure data base. All patients included in the study provided consent at the time of data collection for the use of their data in anonymised data analysis and subsequent publication.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
16/06/2016
Date of last data collection
Anticipated
Actual
16/06/2016
Sample size
Target
3588
Accrual to date
Final
3586
Recruitment outside Australia
Country [1] 8342 0
New Zealand
State/province [1] 8342 0
Auckland

Funding & Sponsors
Funding source category [1] 294756 0
Government body
Name [1] 294756 0
Comprehensive Health
Country [1] 294756 0
New Zealand
Primary sponsor type
Government body
Name
Comprehensive Health, North Shore, Auckland, New Zealand
Address
Comprehensive Care Limited
Building A, 42 Tawa Drive, Albany,
Auckland 0632
PO Box 302163, North Harbour,
Auckland 0751
Country
New Zealand
Secondary sponsor category [1] 293606 0
Individual
Name [1] 293606 0
Dr Felix Ram
Address [1] 293606 0
College of Health
Massey University
Privatre Bag 102904
North Shore Mail Centre
Auckland, 1075
Country [1] 293606 0
New Zealand

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Giving Asthma Support to Patients (GASP) is a new and unique online tool developed to provide asthma education at the point of care, as well as to provide healthcare professionals with skills and knowledge to undertake a structured asthma assessment.

GASP tool is unlike previous tools as it has a built in decision support, based on current guidelines, which encourages best practice. The GASP online tool also includes the following: spirometry testing, asthma symptoms scores, exacerbations, peak flow, triggers, medication adherence, inhaler technique and review of action plans. In this retrospective cohort study we aimed to measure the effectiveness of the GASP tool in improving asthma outcomes such as exacerbations, hospital admissions and medication usage. Patients assessed initially in the month of Novemebr 2008 (before any GASP assessment) were comparted to their own assessment in the month of June 2016. All in between assessment were done on an as required bassis and usually on a three monthly basis from November 2008 to June 2016. However, for this study we are only comparing data obtained in November 2008 to that obtained in June 2016.
Trial website
Trial related presentations / publications
Public notes
Ethics approval was not required as this is a retrospective cohort data analysis (audit) of annoymised patient records and all patients had provided consent for their data to be used for such analysis in future as part of using the GASP tool in their standard care.

Contacts
Principal investigator
Name 69838 0
Dr Felix S F Ram
Address 69838 0
College of Health
Massey University
Private Bag 102904
North Shore Mail Centre
Auckland, 1075
Country 69838 0
New Zealand
Phone 69838 0
+64 9 4140800
Fax 69838 0
Email 69838 0
[email protected]
Contact person for public queries
Name 69839 0
Dr Felix S F Ram
Address 69839 0
College of Health
Massey University
Private Bag 102904
North Shore Mail Centre
Auckland, 1075
Country 69839 0
New Zealand
Phone 69839 0
+64 9 4140800
Fax 69839 0
Email 69839 0
[email protected]
Contact person for scientific queries
Name 69840 0
Dr Felix S F Ram
Address 69840 0
College of Health
Massey University
Private Bag 102904
North Shore Mail Centre
Auckland, 1075
Country 69840 0
New Zealand
Phone 69840 0
+64 9 4140800
Fax 69840 0
Email 69840 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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